Sample container with radiofrequency identifier tag

ABSTRACT

There is provided a sample container comprising a retainer for retaining a sample; and a radiofrequency identifier comprising an antenna for transmitting or receiving radiofrequency energy; an integrated circuit chip connecting with said antenna; and a carrier for the radiofrequency identifier; wherein the radiofrequency identifier is on the carrier and the carrier connects to the retainer.

This application is filed pursuant to 35 U.S.C. 371 as a United StatesNational Phase Application of International Patent Application SerialNo. PCT/EP01/04880 filed on 2 May 2001, which claims priority from GB0013619.2 filed on 6 Jun. 2000 in the United Kingdom.

TECHNICAL FIELD

The present invention relates to a radiofrequency identifier (RFID) tagwhich is attached to a sample container as an identification aid. Inparticular the invention relates to the application of RFID tags toidentify sample containers used in pharmaceutical clinical trials.

BACKGROUND TO THE INVENTION

There is a continued need within research and development organisations,particularly in the chemical and biological fields, to be able toidentify individual samples undergoing preparation or analysis. In thepharmaceutical industry, these samples generally take the form ofclinical, biological or chemical samples. The growing trend towardsautomation of sample preparation and assay within the pharmaceuticalindustry to satisfy new drug discovery, evaluation and clinical trialprogrammes, greatly increase the needs to identify unique samplesaccurately and rapidly.

Clinical trial studies, such as metabolism and toxicity studies, areused to aid development of potential drug candidates. These studies mustcomply with Good Laboratory Practice (GLP) and other regulatoryrequirements to satisfy national authorities where registration of thenew drug is sought. In many cases, additional compliance requirements,such as Good Manufacturing Practice (GMP), must also be satisfied.

The processing, storing and handling of sample data, particularly ofclinical trials samples, requires careful control to ensure data qualityand security. It is now common practice within the pharmaceuticalindustry to attach textual and/or bar coded labels to clinical trialsamples to identify them via a unique bar coded identifier. Whilst theuse of bar codes has greatly improved the speed and accuracy of sampleidentification compared to sample identification based solely on visualtext recognition, such processes are still time consuming and prone toerrors. Considerable time is required to scan, and often re-scan,individual bar coded samples into databases, prior to any samplepreparation or assay. The ‘line of sight’ also imposes restrictions onthe speed and accuracy of reading. These restrictions on readabilityoften lead to samples being manually entered into databases, therebyintroducing more errors and time delays into the process.

The Applicants have now devised a method for identifying and recordingsamples which address the aforementioned problems associated withconventional, bar coded techniques. The method involves the attachmentof a RFID tag to a sample container, the RFID tag having a memorystructure which allows for large amounts of information to be storedthereon. The memory structure can be arranged such that parts of thememory are read-only, other parts are read/write and further parts areencrypted and password protectable. Transfer of information to or fromthe memory is readily achievable by the use of a reader that istypically remote from the sample container. The use of such readers thuseliminates the ‘line of sight’ requirement described above for barcodesand minimises the need for any manual handling. In further aspects, thereader can be arranged to simultaneously read and write to the memory ofmultiple RFID tags on multiple sample containers. The invention may beused alone or in combination with existing identification systems, suchas barcode and textual identifiers.

A principal advantage of the present invention is the ability to storemany types of information in different parts of the memory structure ofthe RFID tag. The information could, for example, include clinical trialcompliance information written to the memory at various time points inthe trial process, thereby providing a detailed and readily accessiblesample history of the clinical trial sample. The information could alsoinclude a unique serial number stored in encrypted form or in a passwordprotectable part of the memory that uniquely identifies the samplecontainer.

U.S. Pat. No. 5,963,136 describes an interactive prescription complianceand life safety system which provides remote and on site verification ofprocedures related to the health status of a patient, including thetaking of medicines. One element of this system is the use of a RFID tagattached to a vial containing a drug prescribed by a medicalpractitioner.

U.S. Pat. No. 5,771,657 describes an automatic prescription dispensingand packaging system whereby empty prescription bottles are labelled andloaded in assigned locations in a carrier. The carriers are identifiedby use of a RFID tag and associated reader.

SUMMARY OF INVENTION

According to one aspect of the present invention there is provided asample container comprising a retainer for retaining a sample; and aradiofrequency identifier comprising an antenna for transmitting orreceiving radiofrequency energy; an integrated circuit chip connectingwith the antenna; and a carrier for the radiofrequency identifier;wherein the radiofrequency identifier is on the carrier and the carrierconnects to the retainer.

The radiofrequency identifier can be any known radiofrequencyidentifier. Such identifiers are sometimes known as radiofrequencytransponders or radiofrequency identification tags. Suitableradiofrequency identifiers include those sold by Phillips Semiconductorsof the Netherlands under the trade marks Hitag and Icode, those sold byAmtech Systems Corporation of the United States of America under thetrade mark Intellitag, and those sold by Texas Instruments of the UnitedStates of America under the trade mark Tagit.

In one aspect, the retainer is selected from the group consisting oftube, vial, well and microscope slide.

In another aspect, the retainer is sealable with a cap. The cap may, forexample, be a screw lid cap or a snap-fit cap.

In a further aspect, the retainer comprises material selected from thegroup consisting of glass, organic polymer and metal.

In one aspect, the antenna is capable of transmitting or receivingradiofrequency energy having a frequency of 50 KHz to 2.5 GHz. The ultrahigh frequency (UHF) spectrum falls within this range. Preferably theantenna is adapted to transmit or receive radiofrequency energy having afrequency of 125 KHz. More preferably, the antenna is adapted totransmit or receive radiofrequency energy having a frequency of 13.56MHz. Most preferably, the antenna is adapted to transmit or receiveradiofrequency energy having a frequency of 2.4 GHz.

In another aspect, the radiofrequency identifier is adhesively mountableon the sample container. The carrier may, for example, be mounted on thesample container by use of an appropriate adhesive. The adhesive shouldbe resistant to the temperature and pressure extremes (such as freezing,boiling, autoclaving) which the sample containers may be exposed to.Similarly, the RFID tag must be capable of functioning followingexposure to high/low temperatures and pressures; typically the tags willoperate following sterilisation in an oven (220° Celsius) or anautoclave (135° Celsius at 3 bar with direct exposure to saturatedsteam) and/or freezing at −200° Celsius during cold storage and/orsample preparation in liquid nitrogen. Preferably, the carrier is arigid disc. More preferably, the carrier is a flexible label. Mostpreferably the carrier is a ring. Optionally, the carrier is mouldableto the retainer or the cap.

In a further aspect, the carrier bears a barcode thereon. The use of abarcode offers an additional means of identification. The RFID tagsherein described may be used in combination and/or integrated with othertraditional product labelling methods including visual text,machine-readable text and dot codes.

In yet another aspect, the carrier encases the radiofrequencyidentifier. Preferably, the carrier forms a hermetic seal for theradiofrequency identifier. More preferably, the carrier comprises aninsulating material. Most preferably, the insulating material comprisesa glass material.

In one aspect, the integrated circuit chip has a read only memory area.

In another aspect, the integrated circuit chip has a write only memoryarea.

In a further aspect, the integrated circuit chip has a read/write memoryarea.

Preferably, the integrated circuit chip has a one-time programmablememory area. More preferably, the one-time programmable memory area hasa unique serial number. Most preferably, the integrated circuit chip hasa pre-set, non-read or writeable memory area.

In one aspect, the integrated circuit chip has plural memory areasthereon. Preferably, any memory area contains data in encrypted form.More preferably, any memory area is password protected.

In a further aspect, the integrated circuit chip has plural memory areasthereon including a read only memory area containing a unique serialnumber, a read/write memory area which can be made read only; and apassword protected memory area containing data in encrypted form.

In another aspect, the sample container retains a biological sample.

Preferably, the biological sample is for use in studies selected fromthe group consisting of clinical trials, pharmacokinetic studies,metabolism studies, toxicity studies and environmental fate studies.

More preferably, the biological sample is derived from material selectedfrom the group consisting of water, soil, prion, virus, fungus, alga,bacterium, insect, nematode, fish, reptile, plant, bird, mammal andhuman.

More preferably, the biological sample is selected from the groupconsisting of blood, plasma, urine, cerebral spinal fluid, faeces, celland tissue. Most preferably, the biological sample is selected from thegroup consisting of protein, peptide, amino acid, antibody,carbohydrate, oligosaccharide, lipid, glycolipid, glyceride,polynucleotide, oligonucleotide and nucleotide.

In a further aspect, the sample container retains a chemical sample.

Preferably, the chemical sample is for use in an analytical assay orsynthesis reaction.

Preferably, the chemical sample is a drug candidate.

Optionally, the chemical sample is an agrochemical. Preferably, theagrochemical is selected from the group consisting of herbicide,insecticide, fungicide, rodenticide, nematocide, acaracide and plantgrowth regulator.

Optionally, the chemical sample is a marking material. Preferably, themarking material is selected from the group consisting of toner, ink,dye, pigment, acid and alkali.

Optionally, the chemical sample is a light-sensitive material.

According to another aspect of the present invention, there is provideda system for identifying a sample container comprising a samplecontainer according to the present invention; a carrier for supportingthe sample container; and a reader for reading data from theradiofrequency identifier by transmitting radiofrequency energy theretoand receiving radiofrequency energy therefrom.

In one aspect, the system comprises a plurality of sample containerssupported within a carrier wherein the reader is capable of reading eachradiofrequency identifier separately by differentiating betweenindividual radiofrequency identifiers within the same antenna field.

Preferably, the carrier is selected from the group consisting of rack,carousel, array, micro well plate, square well plate, collection plateand tube block.

In another aspect, the reader is capable of reading multipleradiofrequency identifiers simultaneously by differentiating betweenindividual radiofrequency identifiers within the same antenna field.

In a further aspect, the system additionally comprises a writer forwriting data to the radiofrequency identifier by transmittingradiofrequency energy thereto. Preferably the writer forms part of thereader, which is thus a ‘reader/writer’. More preferably, thereader/writer is capable of writing to multiple radiofrequencyidentifiers simultaneously by differentiating between individualradiofrequency identifiers within the same antenna field. Advantages ofsuch a capability are both speed and the reduction in transcriptionerrors.

In one aspect, the reader is capable of reading and/or writing to one ormore radiofrequency identifiers simultaneously at low temperature withinthe range of 4° Celsius to −200° Celsius. Preferably, the temperature isin the range of −15° Celsius to −25° Celsius. More preferably, thetemperature is in the range of −75° Celsius to −85° Celsius. Reading of,and writing to, the radiofrequency tag can therefore be conducted in acold environment, such as a freezer or cold room.

In another aspect, the reader is connectable to a sample preparationdevice and the data are producible from the device. Preferably, thedevice is selected from the group consisting of weighing scales, soliddispensing system and liquid dispensing system.

In a further aspect, the system additionally comprises transferring thedata from the reader to an electronic data management system comprisinga memory for storage of data; a microprocessor for performing operationson said data; and a signal output for outputting a signal relating tothe data or the outcome of an operation on the data.

Preferably, the electronic data management system is separate to thereader. More preferably the data are transferable from the reader to theelectronic data management system via a public access or private accessnetwork computer system. The information can therefore be transferredfrom the reader to the electronic data management system via theInternet or a secure Intranet. Preferably the data are in encryptedform.

Optionally, the electronic data management system forms part of thereader.

Preferably, the electronic data management system forms part of arobotics system. More preferably, the robotics system employs an antennato locate the position of the sample container according to the presentinvention. In another aspect, the system additionally comprises a datainput system for user input of data to the electronic data managementsystem. Preferably, the data input system comprises a man-machineinterface. More preferably, the system additionally comprises a displayfor display of data from the electronic data management system to theuser.

It is envisaged that data can be continuously read from samplecontainers within a controlled environment, such as a cold room orfreezer, to determine their identity. These data could, for example, becombined with ongoing assay results which are continuously monitoredwithin the controlled environment, such as chemical stability data, torecord the assay data with time. The data could then be transferred tothe electronic data management system via the Internet or a secureintranet.

According to another aspect of the present invention, there is provideda kit of parts comprising a sample container according to the presentinvention and a reader capable of reading and/or writing to eachradiofrequency identifier separately or simultaneously bydifferentiating between individual radiofrequency identifiers within thesame antenna field.

In a further aspect of the present invention there is provided a readerto identify individual sample containers according to the presentinvention within the same antenna field by transmitting radiofrequencyenergy thereto and by receiving radiofrequency energy therefrom.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments of systems according to the invention will now be describedwith reference to the accompanying drawings in which:

FIG. 1 a is a schematic front perspective of a sample containeraccording to the invention.

FIG. 1 b is a schematic side perspective of the sample container of FIG.1 a.

FIG. 2 is a simplified drawing of the memory of a RFID chip according tothe invention.

FIG. 3 is a schematic representation of a single sample container beingidentified according to the invention.

FIG. 4 is a schematic representation of a reader identifying individualsample containers within a carrier.

FIG. 5 is a schematic representation of a robotic arm system identifyingsample containers at various workstations and/or peripheral devices.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a front perspective showing a RFID tag 20 affixed to asample container 10. Data can be received by, or transmitted from, theRFID chip (not shown) via antenna 26 which is connected to the chip. Theantenna 26 is capable of receiving or transmitting radiofrequency energyover a wide bandwidth, ranging from 50 KHz to 2.5 GHz. A lid 15 may bepressed or screwed into position at the mouth 12 of container 10 toenclose the contents (not shown) of the container.

FIG. 1 b shows a side perspective of the sample container of FIG. 1 a.RFID tag 20 protrudes from the side of container 10 where it may be reador written to by a reader (not shown). To read data on the chip, the tag20 is energised on receiving radiofrequency energy from the reader andreturns information to the reader in radiofrequency waveform.

FIG. 2 is a schematic representation of the memory structure of the RFIDchip 121. Such tags are divided into unique blocks, typically numberingsixteen in total, with data being stored in non-volatile memory EEPROM,the EEPROM having a memory capacity of 512–2000 bits with each blockconsisting of 4 bytes. However, for the sake of simplicity, in theillustration shown in FIG. 2 the tag is divided into four blocks 122–125only.

The first block 122 contains unique tag identifiers such as serialnumbers and any details specified by the purchaser, this informationbeing in a read-only format and being encoded on the tag at the time ofmanufacture such that this information cannot be altered once set.

The second block 123 permits write access conditions to be determinedfor the third and fourth blocks, 124 and 125, respectively, for exampleto allow read and write access to the remaining blocks. This block maybe considered a ‘secret area’ in that access requires mutualauthentication and enciphered data communications are used in this area.The second block 123 may be made read-only once information has beenwritten to it; i.e. it may become one-time programmable.

The third block 124 enables special functionality to be written to thefourth block 125, for example to set encryption capabilities within thisblock 125.

The fourth block 125 can be considered to be a ‘user’ or ‘public’ areain that it may be programmed, by block two 123, such that informationmay be read from or written to it. This is generally the format inoperation, information being read from and written to this area. Accesscan be password protected and data may be in encrypted format to enhancesecurity.

In use, information from block one 122 (e.g. the unique serial number)will generally be used to identify the tag. Identification data (e.g.patient name, sex, age) will be transmitted from a writer (not shown) toblock four 125, where it can stored and accessed by a reader (notshown). Additional sample information data, such as date stamps/originalsample weight or volume, may also be written to this area. Thus specificsamples can be identified from the RFID tag throughout the lifetime ofthe sample; for example, from initial sampling to final chemicalanalysis. Any data generated on a particular sample can be transferredto an electronic database (not shown) where they will be specificallyidentified against the unique identifier on the RFID tag. The electronicdatabase may, for example, be a personal computer or form part of aLaboratory Information Management System (LIMS) and/or electronicinventory system.

FIG. 3 is a diagram of a RFID tag 220 on an individual sample container210 being read by reader 230. The reader may, for example, be a handheld device which transmits radiofrequency energy to the tag 220 andreceives radiofrequency energy therefrom. The unique identifier and/orunique details in the data populated memory on tag 220 will identify theparticular sample container 210. The information on the tag 220 may thenbe transferred from the reader 230 to sensor 245 on a local electronicdatabase 240, such as a personal computer, by wireless means (e.g. infrared energy). Any new data which will be generated for the sample, asidentified by the unique identifier, can then be added to the electronicdatabase 240. The electronic database 240 may transfer the data to, ormay form part of, a LIMS (not shown).

FIG. 4 shows a reader 330 reading sample container 310 held in a samplerack 350. The rack 350 holds a plurality of sample containers 310, eachwith a RFID tag 320. Each tag 320 has a unique identifier encoded on thememory chip (not shown). On receiving radiofrequency energy from thereader 330, tag 320 transmits information as radiofrequency energy tothe antenna 326 on reader 330. This information uniquely identifies thesample container 310. The information may then be transmitted to sensor345 attached to a local electronic database 340 by wireless means, suchas infra red energy. Each sample container 310 will therefore beidentified and any additional data, generated for example in a chemicalanalysis, may be added to the information for the specific sample on thedatabase. The date and time of generation of the data will also berecorded. The database 340 may transfer the information to, or form partof, a LIMS (not shown), thereby providing a complete electronic historyof the clinical trial sample.

FIG. 5 shows a robotic arm system 470 identifying sample contains 410 atworkstations 460–465. The robotic arm system 470 may be used to carryout a series of operations on the samples within each sample container410, such as a chemical reaction/assay. The RFID tags 420 are used toidentify each sample container 410 throughout the procedure.

The robotic arm 472 is free to rotate 360 degrees around its axis,thereby accessing workstations and/or peripheral devices 460 to 465.RFID tags 420 are attached to sample containers 410 within rack 450. Therobotic arm can move the rack 450 to each of the workstations and/orperipheral devices 460–465 in order that different operations arecarried out on the samples within each sample container 410.

In the example shown in FIG. 5, involving a typical chemical analysis, areader/writer 430 attached to the robotic arm 472 identifies each samplecontainer 410 in rack 450 by energising the RFID tag 420 and receivingradiofrequency energy carrying the unique identification number. Havingidentified the sample container 410, a solvent is added to eachcontainer by a liquid dispenser at workstation 460. This information,such as the nature/volume of the liquid and date/time of addition, maybe written (not shown) to the RFID tag 420 by the liquid dispenser. Therack 450 is then moved by the robotic arm 472 to the second workstation461 where the samples in the sample containers 410 are dried. On movingrack 450 to the third work station 462, each sample container 410 isagain identified by the reader 430 and a known volume of diluent added(again this information may be transmitted to the RFID tag 420 by theliquid dispenser—not shown). The rack 450 is moved to the fourth workstation 463 and a liquid reagent added to each sample container 410 by adispenser, following identification by reader 430 on the robotic arm.The dispenser may transmit information regarding the reagent to the RFIDtag 420. Incubation of the sample containers 410 occurs on moving therack 450 to a heated water bath at workstation five 464. The reaction isterminated by the addition of a liquid reagent to each sample container410 at the sixth work station 465 following identification using theRFID tag as described above.

It may be appreciated that any of the parts of the invention hereindescribed which contact the sample (such as a chemical, biological ormedical sample) may be coated with materials such as fluoropolymermaterials which reduce the tendency of the sample to adhere thereto.Suitable fluoropolymers include polytetrafluoroethylene (PTFE) andfluoroethylene propylene (FEP).

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following claims:

1. A system for identifying a sample container comprising: a) a samplecontainer comprising: a retainer for retaining a sample; and aradiofrequency identifier comprising: an antenna for transmitting orreceiving radiofrequency energy; an integrated circuit chip connectingwith said antenna; and a carrier for said radiofrequency identifier;wherein the radiofrequency identifier is on said carrier and the carrierconnects to said retainer; b) a carrier for supporting the samplecontainer; and c) a reader for reading data from the radiofrequencyidentifier by transmitting radiofrequency energy thereto and receivingradiofrequency energy therefrom, wherein the reader is capable ofreading from and/or writing to one or more radiofrequency identifierssimultaneously at low temperature within the range of 4° Celsius to−200° Celsius.
 2. A system according to claim 1, wherein saidtemperature is in the range of −15° Celsius to −25° Celsius.
 3. A systemaccording to claim 1, wherein the temperature is in the range of −75°Celsius to −85° Celsius.
 4. A system for identifying a sample containercomprising: a) a sample container comprising: a retainer for retaining asample; and a radiofrequency identifier comprising: an antenna fortransmitting or receiving radiofrequency energy; an integrated circuitchip connecting with said antenna; and a carrier for said radiofrequencyidentifier; wherein the radiofrequency identifier is on said carrier andthe carrier connects to said retainer; b) a carrier for supporting thesample container; c) a reader for reading data from the radiofrequencyidentifier by transmitting radiofrequency energy thereto and receivingradiofrequency energy therefrom: and d) a writer for writing data to theradiofrequency identifier by transmitting radiofrequency energy thereto,wherein said writer forms part of the reader, and wherein the reader isconnectable to a sample preparation device and said data are produciblefrom said device.
 5. A system according to claim 4, wherein the deviceis selected from the group consisting of weighing scales, soliddispensing system and liquid dispensing system.
 6. A system foridentifying a sample container comprising: a) a sample containercomprising: a retainer for retaining a sample; and a radiofrequencyidentifier comprising: an antenna for transmitting or receivingradiofrequency energy; an integrated circuit chip connecting with saidantenna; and a carrier for said radiofrequency identifier; wherein theradiofrequency identifier is on said carrier and the carrier connects tosaid retainer; b) a carrier for supporting the sample container; c) areader for reading data from the radiofrequency identifier bytransmitting radiofrequency energy thereto and receiving radiofrequencyenergy therefrom, and d) an electronic data management systemcomprising: a memory for storage of data; a microprocessor forperforming operations on said data; and a signal output for outputting asignal relating to the data or the outcome of an operation on the data,wherein said data from the reader is transmitted to said electronic datamanagement system, and wherein the electronic data management systemforms part of a robotics system.
 7. A system according to claim 6,wherein said robotics system employs an antenna to locate the positionof said sample container.